Venous UlcerPhase 1/2NCT05962931
Clinical Trial With Adipose Tissue Stem Cells on Biological Matrix for the Treatment of Venous Ulcer of the Lower Limbs
A Phase 1/2 study testing Bioengineered Artificial Mesenchimal Sheet (BAMS) in people with Venous Ulcer, run by Andalusian Network for Design and Translation of Advanced Therapies at 3 sites in Spain.
Trial summary
Phase I-II, Multicenter, Randomized, Controlled, Proof of Concept Clinical Trial to determine feasibility, safety and efficacy of the use of Allogenic adipose-derived adult mesenchymal stem cells expanded on fibrinhyaluronic biological matrix in the treatment of venous ulcer of the lower limbs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Ulcer
- What is being tested?
- Bioengineered Artificial Mesenchimal Sheet (BAMS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesSpain
- Study dates
- 12 Jul 2023to Jul 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signing of the informed consent (IC) after reading the patient information sheet.
- Over 18 years of both sexes.
- Active or recurrent venous ulcer in the lower extremity with an area between 5-10 cm2
- Grade III injury on the Widmer scale.
- Independence and/or availability to go to the referral center on an outpatient basis.
- Distal pulses in palpable lower limbs (tibial and foot). ABI between 0.8 - 1.3
Who cannot join
- Any pathology for which the investigator considers that compression bandaging is contraindicated and/or previous acute deep vein thrombosis (DVT), within the first 10 days from the onset of symptoms.
- Grade III obesity with a body mass index (BMI) >40; or underweight patients (BMI <18.5).
- Active neoplasia and/or being treated with cytostatics.
- Patients undergoing radiotherapy treatment in areas close to the lesion.
- Clinical signs of colonization or local infection of the lesion.
- Patients with more than one lesion compatible with UV in the same lower limb.
Show all 20Show fewer
- Erysipelas.
- Infectious cellulite.
- Osteomyelitis.
- Lymphangitis.
- Chronic lymphedema.
- Therapy with corticosteroids or immunosuppressants.
- Venous ulcer grade I or II on the Widmer scale.
- Lesions close to possible or diagnosed cancerous lesions.
- Non-localized wounds in the lower extremities.
- Ongoing infection and/or sepsis.
- Critical ischemia in the lower limbs or other venous diseases of unknown origin.
- Immunocompromised patients.
- Dependent patients with severe mobility limitations.
- Dialysis patients.
Trial locations and contacts
3 sites in 1 country.
Olga Férnández López, PhD contact
Spain3 sites, 3 recruiting
- Recruiting
Unidad de A.P. de Alfacar
Alfacar, Granada, 18170
Mª Ángeles Granado Contrelas
- Recruiting
Unidad de A.P. de Atarfe
Atarfe, Granada, 18290
Encarnación González Vigil
- Recruiting
Universidad de Granada
Granada, 18071
Victor Costela Ruiz
About this study
Official title: Phase I-II, Multicenter, Randomized, Controlled, Proof of Concept Clinical Trial to Determine Feasibility, Safety and Efficacy of the Use of Allogenic Adipose-derived Adult Mesenchymal Stem Cells Expanded on Fibrinhyaluronic Biological Matrix in the Treatment of Venous Ulcer of the Lower Limbs
Phase I-II, Multicenter, Randomized, Controlled, Proof of Concept Clinical Trial to determine feasibility, safety and efficacy of the use of Allogenic adipose-derived adult mesenchymal stem cells expanded on fibrinhyaluronic biological matrix in the treatment of venous ulcer of the lower limbs.
- Conditions
- Venous Ulcer
- Being tested
- Bioengineered Artificial Mesenchimal Sheet (BAMS), Standard treatment (Control)
- Medical subject headings
- Varicose Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioengineered Artificial Mesenchimal Sheet (BAMS)Biological
Each patient assigned to the experimental treatment group will receive 4 BAMS (1 BAMS/week) at a concentration of about 360,000 cells/cm2.
Standard treatment (Control)Procedure or surgery
Each patient assigned to the control group will undergo a standard treatment procedure for uncomplicated venous ulcers.
| Study group | Role | What they receive |
|---|---|---|
| Bioengineered Artificial Mesenchimal Sheet (BAMS) | Experimental | Allogenic adipose-derived adult mesenchymal stem cells expanded on fibrinhyaluronic biological matrix Receives: Biological: Bioengineered Artificial Mesenchimal Sheet (BAMS) |
| Standard treatment (Control) | Active comparator | Standard treatment Receives: Procedure: Standard treatment (Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Factibility of Bioengineered Artificial Mesenchimal Sheet measured as the remission of the treated fistula.
To evaluate the factibility of the topical application of CMTAd in a biological matrix of fibrin-hyaluronic acid on venous ulcers (VU).
Measured: Through study completion, an average of 1 year
Safety of Bioengineered Artificial Mesenchimal Sheet measured by the incidence of adverse events
To examine the safety of cutaneous administration of CMTAd in a biological matrix of fibrin-hyaluronic acid on VUs compared to standard treatment.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start12 Jul 2023
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Venous UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andalusian Network for Design and Translation of Advanced Therapies
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Encarnación González Vigil, Principal investigator, Unidad de A.P. de AtarfeMª Ángeles Granado Contrelas, Principal investigator, Unidad de A.P. de AlfacarVictor Costela Ruiz, Study director, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05962931
- Sponsor's protocol ID
- UV/AP/21
- Status last verified
- Jul 2023
- First submitted
- 6 Jul 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Costela-Ruiz VJ, Gonzalez-Vigil E, Espinosa-Ibanez O, Alcazar-Caballero RM, Melguizo-Rodriguez L, Fernandez-Lopez O, Arias-Santiago S. Application of allogeneic adult mesenchymal stem cells in the treatment of venous ulcers: A phase I/II randomized controlled trial protocol. PLoS One. 2025 May 15;20(5):e0323173. doi: 10.1371/journal.pone.0323173. eCollection 2025.
PubMed 40373055
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I-II, Multicenter, Randomized, Controlled, Proof of Concept Clinical Trial to Determine Feasibility, Safety and Efficacy of the Use of Allogenic Adipose-derived Adult Mesenchymal Stem Cells Expanded on Fibrinhyaluronic Biological Matrix in the Treatment of Venous Ulcer of the Lower Limbs
- ClinicalTrials.gov ID
- NCT05962931
- Acronym / sponsor ID
- UV/AP/21
- Conditions
- Venous Ulcer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Andalusian Network for Design and Translation of Advanced TherapiesUniversity, hospital or other
- Study start
- 12 Jul 2023 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase I-II, Multicenter, Randomized, Controlled, Proof of Concept Clinical Trial to determine feasibility, safety and efficacy of the use of Allogenic adipose-derived adult mesenchymal stem cells expanded on fibrinhyaluronic biological matrix in the treatment of venous ulcer of the lower limbs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bioengineered Artificial Mesenchimal Sheet (BAMS) | Experimental | Biological: Bioengineered Artificial Mesenchimal Sheet (BAMS)Allogenic adipose-derived adult mesenchymal stem cells expanded on fibrinhyaluronic biological matrix |
| Standard treatment (Control) | Active comparator | Procedure: Standard treatment (Control)Standard treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signing of the informed consent (IC) after reading the patient information sheet.
- Over 18 years of both sexes.
- Active or recurrent venous ulcer in the lower extremity with an area between 5-10 cm2
- Grade III injury on the Widmer scale.
- Independence and/or availability to go to the referral center on an outpatient basis.
Key exclusion criteria (20 listed)
- Any pathology for which the investigator considers that compression bandaging is contraindicated and/or previous acute deep vein thrombosis (DVT), within the first 10 days from the onset of symptoms.
- Grade III obesity with a body mass index (BMI) >40; or underweight patients (BMI <18.5).
- Active neoplasia and/or being treated with cytostatics.
- Patients undergoing radiotherapy treatment in areas close to the lesion.
- Clinical signs of colonization or local infection of the lesion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bioengineered Artificial Mesenchimal Sheet (BAMS)Each patient assigned to the experimental treatment group will receive 4 BAMS (1 BAMS/week) at a concentration of about 360,000 cells/cm2. | Biological | Bioengineered Artificial Mesenchimal Sheet (BAMS) |
| Standard treatment (Control)Each patient assigned to the control group will undergo a standard treatment procedure for uncomplicated venous ulcers. | Procedure or surgery | Standard treatment (Control) |
Primary outcome
Factibility of Bioengineered Artificial Mesenchimal Sheet measured as the remission of the treated fistula.
Time frame: Through study completion, an average of 1 year
To evaluate the factibility of the topical application of CMTAd in a biological matrix of fibrin-hyaluronic acid on venous ulcers (VU).
Safety of Bioengineered Artificial Mesenchimal Sheet measured by the incidence of adverse events
Time frame: Through study completion, an average of 1 year
To examine the safety of cutaneous administration of CMTAd in a biological matrix of fibrin-hyaluronic acid on VUs compared to standard treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Derived from this study: PubMed 40373055Costela-Ruiz VJ, Gonzalez-Vigil E, Espinosa-Ibanez O, Alcazar-Caballero RM, Melguizo-Rodriguez L, Fernandez-Lopez O, Arias-Santiago S. Application of allogeneic adult mesenchymal stem cells in the treatment of venous ulcers: A phase I/II randomized controlled trial protocol. PLoS One. 2025 May 15;20(5):e0323173. doi: 10.1371/journal.pone.0323173. eCollection 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olga Férnández López, PhD contact
Encarnación González Vigil principal investigator
Unidad de A.P. de Atarfe
Mª Ángeles Granado Contrelas principal investigator
Unidad de A.P. de Alfacar
Victor Costela Ruiz study director
Universidad de Granada
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Bioengineered Artificial Mesenchimal Sheet (BAMS) in people with Venous Ulcer, run by Andalusian Network for Design and Translation of Advanced Therapies at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olga Férnández López, PhD (955 048 366 ext. 0034, ensayosclinicos.radytta.fps@juntadeandalucia.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Factibility of Bioengineered Artificial Mesenchimal Sheet measured as the remission of the treated fistula. (time frame: Through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05962931, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.